Janssen and Bristol-Myers Squibb to Evaluate DARZALEX® in Combination with OPDIVO®

Janssen Biotech has entered a clinical trial collaboration with Bristol-Myers Squibb Company to evaluate the combination of the first CD38-directed cytolytic antibody daratumumab (DARZALEX®) and checkpoint inhibitor nivolumab (OPDIVO®) in Phase 1b/Phase 2 clinical studies in multiple myeloma and several solid tumor types. Nivolumab is developed and commercialized by BMS. Janssen licensed daratumumab from Genmab A/S and is responsible for all global development, marketing and manufacturing.

The multiple myeloma study will evaluate the safety and tolerability of daratumumab in combination with nivolumab with or without pomalidomide and dexamethasone in relapsed/refractory multiple myeloma. The solid tumor studies will evaluate the safety, tolerability and clinical benefit of daratumumab combined with nivolumab in patients with advanced or metastatic tumors, including non-small cell lung, head and neck, pancreatic, colorectal and triple negative breast cancers. Additional tumor types may also be evaluated. Studies are expected to start this year.

"Immunotherapy has vastly changed the way cancer is treated. We are excited to study this novel combination of two potentially synergistic immunotherapies," said Peter F. Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen Research & Development, LLC. "This agreement allows us to extend our footprint in immuno-oncology and will be a significant addition to the growing body of clinical data for daratumumab in combination with other novel agents, in a variety of tumor types."

DARZALEX is the first CD38-directed cytolytic antibody approved anywhere in the world. It was first approved by the U.S. Food and Drug Administration (FDA) in November 2015 as a monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double refractory to a PI and immunomodulatory agent. It is also approved in Europe, Canada and several other countries for a similar patient population.

DARZALEX was more recently approved by the FDA in November 2016 for use in combination with lenalidomide (an immunomodulatory agent) and dexamethasone, or bortezomib (a PI) and dexamethasone, in patients with multiple myeloma who have received at least one prior therapy.DARZALEX received Breakthrough Therapy Designation from the FDA for this indication in July 2016.